meddevicedb.com FDA Device Reference

Review Panel

Ear, Nose, Throat FDA 510(k) Clearances & Devices

Cleared Devices
3,803
Product Codes (page)
27
Latest Decision
1987-02-10

Clearances · page 29 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K870129 VENTILATION TUBES WITH HYDROGEL COATING Richards Medical Co., Inc. ETD Class II 1987-02-10
K864444 SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE Richards Medical Co., Inc. ETA Class II 1987-02-06
K862835 CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE Cooper Lasersonics, Inc. EOQ Class II 1987-02-05
K864443 EGG-TOP TORP AND EGG-TOP PORP Richards Medical Co., Inc. ETA Class II 1987-02-02
K864934 'EXMOOR' SHAH SILICONE DISCS Exmoor Plastics , Ltd. EPP Class I 1987-01-28
K864382 FRAZIER SUCTION TUBE Luxtec Corp. EQH Class I 1987-01-14
K864383 LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS Luxtec Corp. EQH Class I 1987-01-14
K862866 MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE Directed Energy, Inc. EWG Class II 1987-01-09
K862865 MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE Directed Energy, Inc. EWG Class II 1987-01-09
K864277 UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS Unimax Hearing Instruments ESD Class I 1987-01-09
K864823 BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1 Bernafon, Inc. ESD Class I 1987-01-06
K863615 ENTHERMO IRRIGATION UNIT Jedmed Instrument Co. ETP Class I 1986-12-16
K862903 MIDDLE EAR VIEWER AND FLUID COLLECTOR Steven K. Juhn JZF Class I 1986-11-24
K863979 MICROSCREEN I HEARING TESTER Microscreen EWO Class II 1986-11-18
K863984 MODEL 320 TWO CHANNEL AUDIOMETER Virtual Corp. EWO Class II 1986-11-18
K864030 MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID Int'L Hearing Aids, Inc. ESD Class I 1986-11-13
K864029 AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID Int'L Hearing Aids, Inc. ESD Class I 1986-11-13
K864031 MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID Int'L Hearing Aids, Inc. ESD Class I 1986-11-13
K864028 MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID Int'L Hearing Aids, Inc. ESD Class I 1986-11-13
K863975 CUSTOM IN-THE-EAR Gn Danavox, Inc. ESD Class I 1986-11-07
K864180 INTEGRA, CUSTOM IN-THE-EAR HEARING AID Bernafon, Inc. ESD Class I 1986-11-05
K864097 WIDEX HEARING AID MODEL ES2 Widex Hearing Aid Co., Inc. ESD Class I 1986-11-05
K863353 MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) Grason-Stadler, Inc. ETY Class II 1986-11-03
K863225 UNITRON MODEL UL21 HEARING AID Unitron Industries, Inc. ESD Class I 1986-10-24
K860622 STUDEX EAR PIERCING GUNS Onyx Industries, Inc. JYS Class I 1986-10-17
K862981 OTICON I31 INITIALES HEARING AID Oticon Corp. ESD Class I 1986-10-15
K863787 PA EQUALIZER Electone, Inc. ESD Class I 1986-10-14
K862773 PHONIC EAR, MODEL PE475R Phonic Ear, Inc. EPF Class II 1986-10-09
K863382 CANNON NASAL SPLINT Treace Medical, Inc. EPP Class I 1986-10-07
K862406 NOZEES NOSTRIL DILATOR Nozees Co. LWF Class I 1986-09-19
K862592 PHOENIX SYSTEM SEVEN. Nicolet Biomedical Instruments EWO Class II 1986-09-16
K862150 MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) Directed Energy, Inc. EWG Class II 1986-09-04
K862005 LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER Laserscope EWG Class II 1986-08-29
K860678 J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS Jay Kenny Templeton JYS Class I 1986-08-29
K862980 OTICON I31 CITE HEARING AID Oticon Corp. ESD Class I 1986-08-26
K862807 TREACE DRILL SYSTEM Treace Medical, Inc. ERL Class II 1986-08-15
K862770 AUDIOMETER/MASTER HEARING AID MF6 Maico Hearing Instruments, Inc. EWO Class II 1986-08-15
K862026 HA-2000 REAL EAR SPECTROSCOPE And/Or Corp. ETW Class II 1986-08-15
K862769 FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR Maico Hearing Instruments, Inc. LRB Class I 1986-08-13
K862768 FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 Maico Hearing Instruments, Inc. LRB Class I 1986-08-13
K862661 D.L. SCOPE(R) OTOSCOPE North American Medical Products, Inc. ERA Class I 1986-08-08
K862623 I81 INITIALES Oticon Corp. ESD Class I 1986-08-07
K862698 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION Cooper Lasersonics, Inc. LLO Class II 1986-08-05
K862622 I22 CITE Oticon Corp. ESD Class I 1986-08-01
K862754 CUSTOM IN-THE-EAR AND CANAL HEARING AID Cochlear Laboratories, Ltd. ESD Class I 1986-08-01
K862624 I81 CITE Oticon Corp. ERA Class I 1986-08-01
K862621 I22 INITIALES Oticon Corp. ERA Class I 1986-08-01
K862760 HEARING AID, UNITRON MODEL UF11 Unitron Industries, Inc. ESD Class I 1986-07-31
K862670 RIONET HEARING AID HB-35PT Rion Acoustic Instruments, Inc. ESD Class I 1986-07-31
K862169 ALPHA ALL-IN-THE-EAR HEARING AID Authorized Hearing Systems, Inc. ESD Class I 1986-07-22
K862229 PHONIC EAR PE 602 PPCS Phonic Ear, Inc. ESD Class I 1986-07-22
K862162 PHONIC EAR, MODEL PE 1800 Phonic Ear, Inc. ETW Class II 1986-07-18
K860975 MODEL 545-45 LASER FOR EAR, NOSE & THROAT Britt Corp., Inc. EWG Class II 1986-07-18
K862222 INEARSET IES HEARING AID Inearset, Inc. ESD Class I 1986-07-16
K862086 IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 A/S Bruel & Kjaer ETW Class II 1986-07-16
K862545 HEARING AID (ALL-IN-EAR) Vibrasonic, Inc. ESD Class I 1986-07-16
K861369 INCUS/STAPES PROSTHESIS Richards Medical Co., Inc. ETB Class II 1986-07-14
K862496 MICROTEK INTRANASAL SPLINT Microtek Medical, Inc. EPP Class I 1986-07-14
K860460 MICROTEK STAINLESS STEEL PISTON Microtek Medical, Inc. ETB Class II 1986-07-11
K862095 MODEL CA, HEARING AID Fine-Tune ESD Class I 1986-06-26
K862036 MODEL HP HEARING AID Fine-Tune ESD Class I 1986-06-23
K862103 MODEL UC IN-THE-CANAL HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1986-06-23
K861939 MODEL PC HEARING AID Fine-Tune ESD Class I 1986-06-23
K862101 MODEL UM IN-THE-CANAL HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1986-06-23
K862104 MODEL UC SPECTRUM IN-THE-CANAL HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1986-06-23
K862050 LIFESOUND CUSTOM ITE Lifesounds, Inc. ESD Class I 1986-06-23
K862099 DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1986-06-23
K862102 MODEL KM IN-THE-CANAL HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1986-06-23
K862100 MODEL ED BEHIND-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1986-06-23
K861516 WELCH ALLYN TYMPANOMETER Welch Allyn, Inc. ETY Class II 1986-06-10
K861857 PHONIC EAR Phonic Ear, Inc. ETW Class II 1986-06-09
K861532 RX-33S INTRA MINI CANAL MODULE Rexton, Inc. ESD Class I 1986-06-05
K861597 BEHING-THE-EAR HEARING AID SERIES SP Maico Hearing Instruments, Inc. ESD Class I 1986-06-02
K861921 LASER BRONCHOSCOPE SYSTEM Pilling Co. LLO Class II 1986-06-02
K861971 XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL Xomed, Inc. LXB Class II 1986-05-30
K861571 TYPE 6500 HEARING AID ANALYZER Frye Electronics, Inc. ETW Class II 1986-05-30
K861728 RIONET HEARING AID Rion Acoustic Instruments, Inc. ESD Class I 1986-05-27
K861583 CO2 LASER BRONCHOSCOPE SYSTEM Richard Wolf Medical Instruments Corp. LLO Class II 1986-05-21
K860277 MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT Britt Corp., Inc. EWG Class II 1986-05-06
K860992 VOX COMPANION Bloomfield Research and Development, Inc. ESE Class I 1986-05-02
K860940 MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT Micromedics, Inc. ETF Class I 1986-05-02
K860171 VOROBA PROGRAMMABLE AUDITORY COMPARATOR Voroba Technologies Assoc. KHL Class II 1986-05-02
K861492 HEARING AID (ALL IN THE EAR) Crystal Tone Hearing Instruments ESD Class I 1986-05-02
K854637 LEE ELECTRONICS PAL Lee Electronics ESD Class I 1986-04-29
K860993 P.O. VOX Bloomfield Research and Development, Inc. ESE Class I 1986-04-25
K860262 TA-6C - PART NUMBER SLZ 7520 Teledyne Avionics Div. of Teledyne ETY Class II 1986-04-23
K861254 MODEL ST HEARING AID Fine-Tune ESD Class I 1986-04-23
K861113 ER-7C CLINICAL PROBE MICROPHONE Etymotic Research ETW Class II 1986-04-23
K861298 FISCH DRILL IRRIGATOR Jedmed Instrument Co. KAR Class I 1986-04-23
K861045 MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT Sharplan Industries, Inc. LLO Class II 1986-04-23
K860170 VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID Voroba Technologies Assoc. ESD Class I 1986-04-17
K854311 EARLENS Sound Acoustic Systems, Ltd. ESD Class I 1986-04-14
K855146 LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL Laserscope LMS Class II 1986-04-11
K860670 DAHLBERG MODEL UT IN-THE-EAR HEARING AID Dahlberg Electronics, Inc. ESD Class I 1986-04-11
K860759 CHARISMA HEARING AID Bernafon, Inc. ESD Class I 1986-04-11
K860671 DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID Miracle-Ear/Dahlberg, Inc. ESD Class I 1986-04-03
K855059 AUDIANT BONE CONDUCTOR OR A.B.C. Xomed, Inc. LXB Class II 1986-04-03
K861088 BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS Bivona Medical Technologies EWL Class II 1986-04-02
K854124 CRAIGWELL AID HA300 Craigwell Electronics, Ltd. ESD Class I 1986-03-26
K855021 LARYNGEAL MIRROR PRE-WARMER Jedmed Instrument Co. ETF Class I 1986-03-20

3,803 clearances in the Ear, Nose, Throat panel. Data: openFDA.